Patients who take controlled substances for chronic pain often feel stereotyped as “drug seekers” by the clinic staff who provide their medication refills. The patients worry that their pain is not taken seriously. As a result, patients tend to become more pressing in their refill requests, which can feel more like demands than requests to the clinic staff. This causes frustration for patients and clinic staff, and physicians and other providers may become uncomfortable treating the patient's pain. This scenario was common in our large primary care group practice, and we received patient complaints because of it. In this article we describe the proactive refill program we created to stop this unyielding cycle.

The problem

To manage controlled substance refills, some practices have the patient see the provider each month and refill the prescription then. In clinics with high demand or many part-time providers, monthly visits are not always possible. Also, individual clinics, doctors or teams in an organization may handle such refill requests differently, which often results in further patient frustration and staff inefficiencies.

Many practices treat requests for controlled substance refills as an unexpected event – as if we are surprised each month when the patient calls for a refill. This reactive, non-standardized approach leads to more patient phone calls, more time spent processing refill requests, and discontinuity of care if the request must be handled by someone other than the patient's provider.

We've found that for patients who receive a fixed amount of medication each month and have adequately controlled pain symptoms, the monthly medication refill is a predictable event that is best handled when we expect and plan for it.

The refill program

Our refill program allows patients to pick up their prescription each month on the days they are due to be refilled rather than requiring that patients call to request it. While the program is primarily helpful for patients on class II narcotics that must be signed each month by the provider and cannot be called into pharmacies, it can be adapted for other controlled substances as well. For instance, when we expanded the program to a second clinic, we implemented the same program for pediatric patients on controlled substances for attention deficit disorder. Patient satisfaction has improved and office rework has decreased as a result of implementing this program (more on the results later). Here's how our refill program works:

Enrolling patients. The program is used only for patients who are on stable dosages of controlled substances with monthly refills for the same amount of medication. When such a patient is identified, we give the patient information about the refill program. Those who choose to enroll are asked to sign a standard controlled-substances agreement form, which identifies what we expect of the patient regarding his or her narcotic use. Additionally, the patient's provider is given a simple form that verifies essential information about the patient's prescription (e.g., drug name, strength and dosage) and authorizes the patient to enroll in the program (see the sample patient enrollment form). The patient agreement and the patient enrollment form are kept on file and in the patient's chart.

Automating refill reminders. Using a standard group calendar program such as Microsoft Outlook or Lotus iNotes, the staff member or nurse who is responsible for administering the refill program creates a monthly, recurring calendar event for the enrolled patient using the patient's name as the subject line. The calendar event is scheduled on the date the patient's medication is due to be refilled. Access to the group calendar should be restricted to the staff member or members who administer the refill program. Only calendar programs that allow authorized users to determine the account's privacy and security settings should be used for this purpose.

The calendar event should contain key patient information in the notes section of the event: patient ID number, allergies and contact information; pharmacy name and contact information; and medication name, strength, dosage and number of pills dispensed each month. The patient agreement and the enrollment form can be scanned and added as an electronic attachment to the calendar event, if the practice so chooses.

Randomizing toxicology screens. When the staff member creates the calendar event, the patient is assigned a color to be used in the randomization of urine toxicology screening. The staff member ensures that the colors are used on a rotating basis and assigns the next color in the sequence. For example, a practice might use blue, green, yellow and red in that order. If the last patient was assigned green, then the next patient should be assigned yellow. The number of colors a practice uses should be based on the number of toxicology screens the clinic wishes to perform. By dividing the number of patients enrolled in the program by the number of colors used in rotation, we determine the actual number of urine toxicology screens that will be completed each month. For example, if 100 patients are enrolled in the program and you assign five colors, then you will have 20 toxicology screens per month.

The staff member formats the calendar event to reflect the color assigned to the patient. In Microsoft Outlook, the event itself is colored using the calendar event color-formatting features. In Lotus iNotes, the event is labeled with the name of the color (i.e., Smith, Joseph: BLUE).

Preparing the refills. Each Monday, the staff member who administers the refill program prepares the refill prescriptions for the upcoming week. For example, on Monday, Feb. 1, the staff member prepares the prescriptions for Monday, Feb. 8 through Sunday, Feb. 14. This entails viewing the calendar event for each patient whose refill falls in the week that is being prepared, writing the prescription and giving it to the provider for his or her review and signature. If the provider is scheduled to be out of the office, the prescriptions should be prepared and signed in advance. This increases the safety and continuity of the refills and eliminates the need for partners or colleagues to sign the prescriptions for one another's patients. If a provider has an unscheduled absence, the prescriptions should be signed as soon as the provider is available, and because the prescriptions are prepared a week in advance there should still be time to have the prescriptions approved by the date they are due, barring an extended, unscheduled absence.

When the prescriptions for that week are signed, the staff member locks the prescriptions in a secure area. At the start of each day the staff member administering the refill program removes the prescriptions for the day from the secure area and places them in a secure area at the front desk for patient pick-up. He or she also pulls a colored piece of paper out of a bowl to randomly select the color that will be used to determine that day's toxicology screens and places a sign at the front desk stating the color of the day.

Administering the refills. When the patient arrives at the front desk to pick up his or her prescription, the staff member compares the patient's assigned color shown on the calendar event to the color of the day. If the patient's color is not the same as the color of the day, then the patient is given the prescription. If the patient's color is the same as the color of the day, then the patient is asked to provide a urine toxicology screen (UTS) sample. Once the patient provides the urine sample, the patient is given his or her prescription while the urine sample is sent to the lab for analysis. If a patient's UTS returns positive, we act according to our patient agreement form and use an intervention program that is outlined in the article “Terminating a Patient: Is It Time to Part Ways?” FPM, September 2005. We do this even if the lab report has been delayed, as is sometimes the case.

If a patient's refill due date falls on a weekend or holiday, the patient can pick up the prescription the preceding business day. The next month, however, the refill date will occur on the recurring date as originally scheduled, thus ensuring that the prescription is not refilled earlier each month. We also include a note on the prescription that is entered into our clinics' electronic health record systems to indicate that the prescription was picked up early that month. (For information on using an EHR to prescribe controlled substances, see "E-prescribing of controlled substances.")

Handling dosing changes. When an enrolled patient's provider wishes to make a dosing change, he or she simply notifies in writing the staff member who administers the refill program, and the staff member updates the patient's calendar event to reflect the change. The change is then made in the patient's next refill. However, if an enrolled patient has an acute change in pain or is hospitalized, the patient's provider must determine if the pain is controlled and stable before the patient can restart the refill program.

E-PRESCRIBING OF CONTROLLED SUBSTANCES

On June 1, 2010, the Drug Enforcement Administration's (DEA) “Electronic Prescription for Controlled Substances” rule went into effect, giving physicians the option of writing prescriptions for controlled substances electronically. The rule also permits pharmacies to receive, dispense and archive electronic prescriptions. Among other things, the rule is designed to increase efficiencies and reduce wait times for patients having prescriptions filled and potentially reduce prescription forgeries.

Physicians who are interested in e-prescribing controlled substances should read the DEA's instructions. The process requires that physicians obtain a two-factor authentication credential or digital certificate through a federally approved credential service provider (CSP) or certification authority (CA), which will conduct identity proofing. Physicians can contact their e-prescribing software company for help in determining which CSP or CA to use.

The results

Our process for randomizing toxicology screens has helped eliminate the patient perceptions of bias or stereotyping that were occurring before we began the program. During the quarter before implementation, patient complaints related to the timeliness of calls and refills and pleasantness of clinic staff averaged 3.74 complaints per 1,000 visits. We then enrolled 200 patients on chronic, narcotic pain medications into the refill program, and following the implementation of the program, patient complaints on the same measure dropped by 42 percent, to 2.16 complaints per 1,000 visits. Before implementation, the most common patient complaint we received was having to wait too long to receive medications. This number was cut in half. Even though this data reflects all types of office visits, not just ones involving the patients we are treating with pain medications, we are confident that the improvement is the result of better managing pain medication refills.

We administered staff and physician satisfaction surveys when we began the pilot program, but the response rate was very low. We are currently collecting pre-implementation surveys from staff and physicians who have not yet begun the program. We will then follow up with a post-implementation survey.

We expected that the program would find an increase in the number of patient-agreement violations, but we are happy to report the number is low. However, we are continuing to develop an ever-more standardized approach to handling these violations. Two common violations have involved the absence of the prescribed medication on the UTS and the presence of other illegal substances on the UTS.

It can work for you

Implementing a refill program like ours is achievable in any practice and with very few resources. The forms included with this article, an electronic calendar program that allows scheduling recurring events and permits access only to limited staff are all you need to get started. Once patients begin the refill program, staff rework and phone calls decrease, patient satisfaction increases, and the tension between clinic staff and patients improves.

CONTROLLED SUBSTANCE REFILL PROGRAM: PATIENT AGREEMENT FORM

Treatment Agreement for Chronic Opioids

We want to ensure that patients and caregivers have clear communication and safe, effective procedures when patients use opioids.

EFFECTIVENESS: For most patients and pain conditions, opioids are effective pain-relieving medications. However, it is possible opioids will not work well for you and your pain.

SAFETY: Most people can take these drugs safely, but some people do experience side effects. (See below.)

SIDE EFFECTS: Most patients do not have serious side effects or drug interactions. Unfortunately, some do experience side effects and must stop the medication(s). Common side effects include constipation, itching, nausea, vomiting, sedation or lightheadedness. Uncommon reactions include swelling in the legs, water on the lungs, trouble breathing (especially if you have emphysema/COPD or are on other narcotics), mental slowing and loss of coordination, lowering of sex drive, decreased testosterone (male sex hormone) and addiction. Note: Pregnant women using opioids could make their newborn child dependent upon opioids. If you are pregnant, you need to alert your health care provider.

DEPENDENCE: Dependence is not the same as addiction. Many people who take opioids daily will become dependent on them. Dependence is when your body adapts to the medication and then experiences withdrawal if the medication is stopped or lowered too quickly. Withdrawal symptoms include moodiness, aches and pains, sweating, diarrhea, abdominal pain and even seizures.

ADDICTION: Addiction is not the same as dependence. While many people become dependent on daily opioids, only a small percentage of these people will become addicted. Addiction is characterized by behaviors such as loss of control of drug use, compulsive use and craving, and continued use despite harm or risk to the person. When people are addicted, they are not taking opioids simply to treat the pain.

GOALS: The goals of chronic pain management are to:

Improve your ability to function in your daily life,

Lower your pain.

TREATMENT OPTIONS:

Medications,

Counseling, relaxation training, hypnosis and meditation,

Chiropractic care, massage, acupuncture and physical therapy,

Surgery and injections.

WHAT YOU NEED TO DO:

Realize that opioid therapy is only one part of treatment.

Remain active every day and try to increase activity a little bit at a time.

Use your medications ONLY as directed by your provider.

Work with your provider and follow treatment recommendations in addition to taking prescribed medications.

Dr. ___________________________________ and staff have explained the risks and benefits of chronic opioid therapy for my pain.

I, ______________________________________, understand that I must comply with the following rules or I will not be given opioids. I will fill the prescription at one and only one pharmacy.

I will take the medication, ___________________________________, as it was prescribed and only in that way.

I will not increase the dose or stop the medication unless asked to do so by my provider or my provider's partner.

I will report any worrisome side effect soon after it begins.

I will follow through on appointments that may help me with chronic pain and functioning. These may include physical and occupational therapy, counseling and other mental health practices, neurosurgery, neurology and orthopedics. Consistent failure to keep these appointments and therapies may result in the stopping of the opioid medications.

If prescribed, I will use medications other than opioids to control pain.

I will accept opioids for chronic pain from my provider only.

I will not share, exchange or sell my opioids, as the law prohibits those actions. I understand that my provider will report serious concerns of drug misuse to any and all authorities for investigation.

I will not use illegal/street drugs (this includes marijuana). I will not use narcotic medications unless provided to me from my provider.

I agree to provide samples for random drug testing when asked. If I fail to provide the sample when asked or if the results are unsatisfactory, I may forfeit the right to continue receiving the medication.

If my provider is concerned that I might have a substance abuse problem, I must agree to an evaluation by a specialist in abuse/addiction. If the evaluation suggests I have a drug abuse problem, my provider may stop my medication in a way that does not cause withdrawal symptoms.

I will not get early refills unless something has dramatically changed and then only if my provider agrees.

I recognize that opioids by themselves, in combination with alcohol or in combination with other medications can result in unclear thinking and loss of coordination. I agree to contact my provider if these symptoms arise. I should not drive or operate equipment if I have these side effects.

It is my responsibility to keep my medications safe. If opioids are lost, damaged or stolen, the medication may or may not be refilled early. Each case will be looked at individually. If the medication is stolen, I must file a police report and submit the number for verification to my provider's office. Again, stolen medications may or may not be refilled. If a refill is given, it will be given only once.

If a new condition develops that causes acute pain, I have the right to expect appropriate treatment for that new condition from the provider treating me for the new condition. I should not be required to increase the use of my chronic pain medication for a serious and new pain.

I understand that if my provider does not feel I am following through adequately with the treatment plan, my provider may lower or stop the opioid altogether.

I understand that my provider may decide to stop the opioid if after increasing it adequately, my pain and function have not responded positively.

By signing this form, I authorize my provider's office to contact any and all groups and organizations involved with my care and involved with the investigation of medication and drug abuse. I give permission to my provider to discuss my care with past caregivers, all pharmacies and policing agencies. This also gives these caregivers and pharmacies permission to share with my provider information about my past treatments and care.

About the Authors

Dr. Willis is associate professor of family medicine at Indiana University School of Medicine. She is also chief medical officer of quality and medical management at Indiana University Medical Group – Primary Care in Indianapolis. Gerald Eaton is a commercial airline pilot and an ABSN nursing student at Marian University in Indianapolis. Dr. MacKie is assistant professor of clinical medicine at Indiana University School of Medicine and medical director of the Integrative Pain Center at Wishard Health Services in Indianapolis. Author disclosure: nothing to disclose.